Surgical Bending Instrument

ABSTRACT

An apparatus and a method are provided for a surgical bending instrument for bending surgical implants. The surgical bending instrument comprises a body including a longitudinally extending threaded hole. A shaft comprising a threaded portion is rotatably engaged within the threaded hole. A handle is coupled to a proximal end of the shaft, and a distal extension of the shaft comprises a driver. A distal force applicator comprises the driver centered between a first grip and a second grip. In some embodiments, the distal force applicator is configured to retain a surgical staple, such that the surgical staple may be changed to a distracted configuration suitable for implantation at a bone fixation or fusion site of a patient. In some embodiments, the distal force applicator is configured to bend a bone fusion plate so as to tailor the plate to specific anatomy of the patient&#39;s bone.

PRIORITY

This divisional application claims the benefit of and priority to U.S.patent application Ser. No. 15/041,959 filed on Feb. 11, 2106 and U.S.Provisional Application, entitled “Surgical Bending Instrument,” filedon Feb. 14, 2015 having application Ser. No. 62/116,387.

FIELD

The field of the present disclosure generally relates to securing bonestogether. More particularly, the field of the disclosure relates to anapparatus and a method for a surgical bending instrument for implantingsurgical implants at bone fixation or fusion sites of a patient.

BACKGROUND

Surgical staples or a fusion bone plate implant utilized in conjunctionwith one or more fasteners may be used to generate compression andstability at a bone interface. An implant generally serves to stabilizebones, or bone parts, relative to one another so as to promote bonefusion. In many applications, surgical staples, or bone plates andfasteners are used to fuse bones, or bone parts, of the human body, suchas bones in the foot, the ankle, the hand, the wrist, as well as variousother portions of the body. Surgical staples are particularlyadvantageous in the hands and feet due to a low dorsal profile of thestaples once they are implanted. Furthermore, during the course ofcertain medical procedures, a surgeon may immobilize one or more bonesor bone fragments by stabilizing the bones together in a configurationwhich approximates the natural anatomy. To this end, the surgeon may usefasteners to attach the bones to a bone plate implant so as to hold thebones in alignment with one another while they fuse together.

SUMMARY

An apparatus and a method are provided for a surgical bending instrumentfor bending surgical implants. The surgical bending instrument comprisesa body including a longitudinally extending threaded hole. A shaftcomprising a threaded portion is rotatably engaged within the threadedhole. A handle is coupled to a proximal end of the shaft, and a distalextension of the shaft comprises a driver. A distal force applicatorcomprises the driver centered between a first grip and a second grip. Insome embodiments, the distal force applicator is configured to retain asurgical staple, such that the surgical staple may be changed to adistracted configuration suitable for implantation at a bone fixation orfusion site of a patient. In some embodiments, the distal forceapplicator is configured to bend a bone fusion plate so as to tailor theplate to specific anatomy of the patient's bone. The surgical bendinginstrument may be packaged into sterile surgery-specific kits comprisingother surgical tools, such as drill guides, drill sizers, tamps,forceps, staple removal tools, drills, temporary pins, drill depthstops, fusion bone plates, bone plate fasteners, compression screws, andthe like.

In an exemplary embodiment, a surgical bending instrument for bendingsurgical implants comprises a body supporting a distal force applicatorand a proximal handle; a first grip and a second grip of the distalforced applicator configured to retain the surgical implant; and adriver of the distal force applicator configured to exert adistally-directed force so as to bend the surgical implant.

In another exemplary embodiment, a shaft is threadably engaged within alongitudinally extending hole within the body, a distal extension of theshaft comprising the driver, and a proximal handle is fixedly coupled toa proximal end of the shaft. In another exemplary embodiment, the driverand the shaft are separate components that are engaged with one another.In another exemplary embodiment, the shaft communicates mechanicalforces applied at the proximal handle to the driver. In anotherexemplary embodiment, rotating the proximal handle relative to the bodymoves the driver longitudinally relative to the body. In anotherexemplary embodiment, twisting the proximal handle clockwise moves thedriver distally into contact with the crown, such that the surgicalstaple is clasped between the grips and the driver, wherein furtherclockwise twisting of the proximal handle changes the surgical staplefrom an initial configuration to a distracted configuration suitable forimplantation across a bone fusion or fixation site of a patient. Inanother exemplary embodiment, twisting the proximal handlecounterclockwise retracts the driver proximally away from the crown,allowing the surgical staple to relax from the distracted configurationand compress the bone fusion or fixation site.

In another exemplary embodiment, a lever comprising a wheel and aperipheral cam is rotatably mounted on a pivot within the body, suchthat when the lever is moved proximally, the cam forceably pushes thedriver so as to exert a distally-directed force onto the surgicalimplant. In another exemplary embodiment, a lever comprising a wheel anda peripheral cam is rotatably mounted on a pivot within the body, suchthat moving the lever proximally causes the cam to exert adistally-directed force onto the surgical implant. In another exemplaryembodiment, the surgical bending instrument comprises a rigid materialsuitable for bending surgical implants.

In another exemplary embodiment, the distal force applicator isconfigured to retain a surgical staple, such that the surgical staplemay be changed to a distracted configuration suitable for implantationat a bone fixation or fusion site of a patient. In another exemplaryembodiment, the surgical staple is indicated for fixation of osteotomiesand joint arthrodesis of the hands and feet. In another exemplaryembodiment, the distal force applicator is configured to bend a bonefusion plate so as to tailor the plate to specific anatomy of apatient's bone.

In another exemplary embodiment, the first and second grips areconfigured to support a crown of a surgical staple when the driver isplaced into forceable contact with the center of the crown. In anotherexemplary embodiment, the driver and the grips operate to retain thesurgical staple within the distal force applicator, thereby facilitatingimplanting the staple into the patient. In another exemplary embodiment,the first and second grips engage the surgical staple on opposite sidesof the crown, thereby preventing the surgical staple from becomingdislodged from the distal force applicator during implantation into apatient. In another exemplary embodiment, the first and second gripshave a separation distance comparable with the length of the crown. Inanother exemplary embodiment, the first and second grips have anadjustable separation distance so as to facilitate using the surgicalbending instrument with a variety of differently-sized staples.

In another exemplary embodiment, the surgical bending instrument ispackaged into sterile surgery-specific kits comprising other surgicaltools, such as drill guides, drill sizers, tamps, forceps, stapleremoval tools, drills, temporary pins, drill depth stops, fusion boneplates, bone plate fasteners, compression screws, and the like.

In an exemplary embodiment, a method of using a surgical bendinginstrument for implanting a surgical staple at a bone fixation or fusionsite of a patient comprises loading the surgical staple into a distalforce applicator of the surgical bending instrument, such that thesurgical staple is in contact with a first grip and a second grip;advancing a driver into forceable contact with a crown of the surgicalstaple, the surgical staple being clasped between the first grip, thesecond grip, and the driver; distracting the surgical staple, such thata first leg and a second leg of the surgical staple are parallel to oneanother; inserting the surgical staple through an incision and slidingthe first and second legs into parallel holes drilled across a bonefusion or fixation site of the patient; retracting the driver from thecrown so as to allow the surgical staple to compress the bone fusion orfixation site; disengaging the first and second grips from the crown;pushing the surgical staple into the parallel holes until the crown isin contact with the patient's bone; and closing the incision by way ofsuturing.

In another exemplary embodiment, advancing further comprises rotating aproximal handle clockwise so as to move the driver distally into contactwith the crown, the driver being connected to the proximal handle by wayof a threaded shaft extending longitudinally through the surgicalbending instrument. In another exemplary embodiment, distracting thesurgical staple further comprises twisting the proximal handle clockwiseto move the driver distally into the crown until the first and secondlegs are parallel with one another. In another exemplary embodiment,retracting further comprises rotating the proximal handlecounterclockwise so as to move the driver proximally away from thecrown, thereby allowing the first and second legs to bend toward oneanother.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings refer to embodiments of the present disclosure in which:

FIG. 1 illustrates an upper perspective view of an exemplary embodimentof a surgical bending instrument in accordance with the presentdisclosure;

FIG. 2 illustrates a lower perspective view of an exemplary embodimentof a distal force applicator, according to the present disclosure;

FIG. 3A illustrates a ghost view of an exemplary embodiment of asurgical bending instrument retaining a surgical staple in an initialconfiguration, according to the present disclosure;

FIG. 3B illustrates a ghost view of the exemplary embodiment of thesurgical bending instrument illustrated in FIG. 3A distracting thesurgical staple in accordance with the present disclosure;

FIG. 4A illustrates a ghost view of an exemplary embodiment of asurgical bending instrument retaining a surgical staple in an initialconfiguration, according to the present disclosure;

FIG. 4B illustrates a ghost view of the exemplary embodiment of thesurgical bending instrument illustrated in FIG. 4A distracting thesurgical staple in accordance with the present disclosure;

FIG. 5A illustrates an upper perspective view of an exemplary embodimentof a surgical bending instrument retaining a surgical staple in aninitial configuration in accordance with the present disclosure; and

FIG. 5B illustrates an upper perspective view of the exemplaryembodiment of the surgical bending instrument illustrated in FIG. 5Adistracting the surgical staple in accordance with the presentdisclosure.

While the present disclosure is subject to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and will herein be described in detail. Theinvention should be understood to not be limited to the particular formsdisclosed, but on the contrary, the intention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the present disclosure.

DETAILED DESCRIPTION

In the following description, numerous specific details are set forth inorder to provide a thorough understanding of the present disclosure. Itwill be apparent, however, to one of ordinary skill in the art that theinvention disclosed herein may be practiced without these specificdetails. In other instances, specific numeric references such as “firstimplant,” may be made. However, the specific numeric reference shouldnot be interpreted as a literal sequential order but rather interpretedthat the “first implant” is different than a “second implant.” Thus, thespecific details set forth are merely exemplary. The specific detailsmay be varied from and still be contemplated to be within the spirit andscope of the present disclosure. The term “coupled” is defined asmeaning connected either directly to the component or indirectly to thecomponent through another component. Further, as used herein, the terms“about,” “approximately,” or “substantially” for any numerical values orranges indicate a suitable dimensional tolerance that allows the part orcollection of components to function for its intended purpose asdescribed herein.

In general, the present disclosure describes an apparatus and a methodfor a surgical bending instrument for bending surgical implants. Thesurgical bending instrument comprises a body including a longitudinallyextending hole, at least of portion of which comprising threads. A shaftcomprising a threaded portion passes through hole and is rotatablyengaged with the threads in the hole. A handle is fixedly coupled to aproximal end of the shaft, and a distal extension of the shaft comprisesa driver. A distal force applicator comprises a first grip, a secondgrip, and the driver centered between the first and second grips. Insome embodiments, the distal force applicator is configured to retain asurgical staple, such that the surgical staple may be changed to adistracted configuration suitable for implantation at a bone fixation orfusion site of a patient. In some embodiments, the distal forceapplicator is configured to bend a bone fusion plate so as to tailor theplate to specific anatomy of the patient's bone.

FIG. 1 illustrates a perspective view of an exemplary embodiment of asurgical bending instrument 100 in accordance with the presentdisclosure. The surgical bending instrument 100 comprises a proximalhandle 104, a body 108, and a distal force applicator 112. In theembodiment illustrated in FIGS. 1-2, a surgical staple 116 is shownloaded within the distal force applicator 112, such that the surgicalstaple 116 is in a distracted configuration suitable for implantation ata bone fixation or fusion site of a patient. The surgical staple 116generally is of the variety indicated for fixation of osteotomies andjoint arthrodesis of the hands and feet. As such, the surgical staple116 preferably is comprised of a metal alloy exhibiting shape memory andsuperelastic properties, such as Nitinol or other similar material. Itshould be understood, however, that the surgical bending instrument 100is not to be limited to distracting surgical staples, but rather may beused in various other capacities, such as by way of non-limitingexample, bending a bone fusion plate so as to tailor the plate tospecific anatomy of a patient's bone being treated.

As best illustrated in FIG. 2, the distal force applicator 112 comprisesa first grip 120, a second grip 124, and a driver 128 centered therebetween. The first and second grips 120, 124 are configured to cooperateso as to support a crown 132 of the surgical staple 116 when the driver128 is placed into forceable contact with the center of the crown 132.The forces on the crown 132 due to the driver 128 and the grips 120, 124operate to retain the surgical staple 116 within the distal forceapplicator 112, thereby facilitating implanting the staple into thepatient. As shown in FIG. 2, the first and second grips 120, 124 areconfigured to engage the surgical staple 116 on opposite sides of thecrown 132. As will be appreciated, engaging the crown 132 on oppositesides advantageously prevents the staple from becoming dislodged fromthe distal forced applicator 112 during distracting the staple orimplantation into the patient.

Preferably, the first and second grips 120, 124 have a separationdistance comparable with the length of the crown 132. Thus, asillustrated in FIGS. 3A-3B, the first grip 120 is positioned near afirst leg 136 of the surgical staple 132, and the second grip 124 ispositioned near a second leg 140 of the staple. It will be appreciated,therefore, that the distal force applicator 112 of the surgical bendinginstrument 100 is configured to be used with specific sizes of surgicalstaples 116. In some embodiments, the surgical bending instrument 100may be configured with an overall size so as to be used with specificsizes of surgical staples 116. In some embodiments, a color-matchingsystem may be utilized to indicate to the surgeon that certain surgicalstaples 116 may be implanted by way of the surgical bending instrument100. Further, in some embodiments, the first and second grips 120, 124may have an adjustable separation distance so as to facilitate using thesurgical bending instrument 100 with a variety of differently-sizedstaples.

FIGS. 3A and 3B illustrate ghost views of the exemplary embodiment ofthe surgical bending instrument 100 illustrated in FIGS. 1-2. A shaft144 passing through the body 108 comprises a threaded portion 148 andthe above-mentioned driver 128. In the illustrated embodiment, thedriver 128 comprises a distal extension of the shaft 144, having anarrower diameter than proximal portions of the shaft 144. In someembodiments, however, the driver 128 and the shaft 144 are separatecomponents which are engaged with one another. It will be appreciatedthat the shaft 144 communicates mechanical forces applied at theproximal handle 104 to the driver 128, and thus to the crown 132 of thestaple. In the illustrated embodiment, the threaded portion 148 isrotatably engaged with similar threads within a hole 152 extendinglongitudinally through the body 108. The shaft 144 is fixedly coupledwith the proximal handle 104 such that rotating the proximal handle 104relative to the body 108 rotates the shaft 144 within the hole 152, andthus moves the driver 128 longitudinally relative to the body 108.

As best illustrated in FIG. 3A, when the driver 128 is not in contactwith the crown, the surgical staple 116 is in an initial configurationwherein the first leg 136 and the second leg 140 of the staple bendtoward one another. During operation of the surgical bending instrument100, twisting the proximal handle 104 clockwise, as viewed from theperspective of a surgeon operating the instrument 100, advances theshaft 144 and moves the driver 128 distally toward the crown 132. Oncethe driver 128 contacts the center of the crown 132, the surgical staple116 becomes clasped between the grips 120, 124 and the driver 128.Further clockwise twisting of the proximal handle 104 exerts anincreasing degree of force onto the crown 132 by the grips 120, 124 andthe driver 128. As will be appreciated, the distally-directed force dueto the driver 128 and proximally-directed forces due to the grips 120,124 cause a corresponding distraction of the first and second legs 136,140. Thus, clockwise twisting of the proximal handle 104 enables thesurgeon to change the surgical staple 116 from the initialconfiguration, shown in FIG. 3A, to a distracted configuration whereinthe first and second legs 136, 140 are forced into a parallelrelationship, as illustrated in FIG. 3B.

Once the surgical staple 116 is in the distracted configuration, thesurgeon may use the surgical bending instrument 100 to slide the firstand second legs 136, 140 into parallel holes drilled across a bonefusion or fixation site of a patient. It will be appreciated that thethreaded portion 148 keeps the driver 128 in contact with the crown 132,thereby maintaining the distracted configuration of the surgical staple116 during implantation. The surgeon may insert the first and secondlegs 136, 140 into the parallel holes until the first and second grips120, 124 come into contact with the patient's bone. The surgeon may thentwist the proximal handle 104 counterclockwise so as to retract thedriver 128 proximally away from the crown 132, thereby allowing thesurgical staple 116 to relax from the distracted configuration. Theshape memory and superelastic properties of the material comprising thesurgical staple 116 ensure that the staple advantageously compresses thebones to be fused as the staple attempts to return to the initialconfiguration illustrated in FIG. 3A. Once the driver 128 has beensuitably retracted from the crown 132, the surgeon may disengage thefirst and second grips 120, 124 from the crown and then use a tamp topush the legs 136, 140 into the parallel holes until the crown 132 is indirect contact with the bone. The surgeon may then close the incision byway of suturing.

As will be recognized, some surgical procedures may necessitate removinga surgical staple, such as the surgical staple 116, from a bone fusionor fixation site of a patent. It is envisioned that the surgeon may liftthe crown 132 away from the patient's bone surface by way of a suitableremoval tool so as to create enough clearance for the surgeon to engagethe grips 120, 124 between the bone and the crown 132. With the firstand second grips 120, 124 suitably engaged with the crown 132, thesurgeon may turn the proximal handle 104 clockwise to distally advancethe driver 128 into contact with the center of the crown 132. Upontwisting the proximal handle 104 so as to place the surgical staple 116into the distracted configuration illustrated in FIG. 3A, the surgeonmay use the surgical bending instrument 100 to pull the first and secondlegs 136, 140 free of the patient's bone.

FIGS. 4A and 4B illustrate ghost views of an exemplary embodiment of asurgical bending instrument 160 retaining the surgical staple 116 inaccordance with the present disclosure. The surgical bending instrument160 illustrated in FIGS. 4A-4B is similar to the surgical bendinginstrument 100 illustrated in FIGS. 1-2, with the exception that thesurgical bending instrument 160 comprises a side lever 164 coupled witha driver 168. The side lever 164 comprises a wheel 172 which isrotatably mounted on a pivot 176 within a body 180 of the surgicalbending instrument 160. The wheel 172 is in sliding contact with aproximal portion of the driver 168, such that the side lever 164 may berotated from a distal position, illustrated in FIG. 4A, to a proximalposition as shown in FIG. 4B. The wheel 172 further comprises a cam 184configured to push the driver 168 distally within the body 180 into thecrown 132 when the side lever 164 is rotated to the proximal position.As will be appreciated, the cam 184 and the driver 168 exert adistally-directed force onto the crown 132, thereby distracting thesurgical staple 116, as illustrated in FIG. 4B and described herein withrespect to FIGS. 3A and 3B.

It will be appreciated that moving the side lever 164 to distract thesurgical staple 116 requires a degree of force to be placed onto thelever. A proximal surface 188 of the body 180 advantageously facilitatesgrasping and stabilizing the surgical bending instrument 160 while theside lever 164 is moved during distraction of the surgical staple 116. Anarrow midsection 192 of the body 180 further enables grasping andstabilizing the surgical bending instrument 160 during distraction ofthe staple 116.

FIGS. 5A and 5B illustrate proximal views of an exemplary embodiment ofa surgical bending instrument 196 retaining the surgical staple 116 inaccordance with the present disclosure. The surgical bending instrument196 illustrated in FIGS. 5A and 5B is similar to the surgical bendinginstrument 160 illustrated in FIGS. 4A-4B, with the exception that theinstrument 196 comprises a center lever 200 rotatably positioned withinan opening 204 of a body 208. As best illustrated in FIG. 5A, the centerlever 200 comprises a wheel 212 and a cam 216 positioned on a peripheryof the wheel. The wheel 212 is rotatably mounted on a pivot 220 withinthe body 208. Unlike previously described embodiments, in the embodimentof FIGS. 5A-5B, the wheel 212 is in direct contact with the crown 132,in absence of a separately, coupled driver. In the embodimentillustrated in FIGS. 5A-5B, the cam 216 operates substantially similarlyto the driver described herein. It will be appreciated that the cam 216is positioned on the wheel so as to exert a distally-directed force onthe crown 132 when the center lever 200 is moved from a distal position,illustrated in FIG. 5A, to a proximal position shown in FIG. 5B. Asdescribed herein, the distally-directed force on the crown 132 distractsthe surgical staple 116 such that the staple may be implanted in thebone of the patent.

As best illustrated in FIG. 5B, the center lever 200 further comprises aslot 224 adjacent to the wheel 212. It will be appreciated that the slot224 advantageously allows the center lever 200 to be placed into thedistal position while the surgical staple 116 is clasped in the firstand second grips 120, 124. In some embodiments, the slot 224 isconfigured to cooperate with the first and second grips 120, 124 so asto retain the surgical staple 116 in the surgical bending instrumentwhile the staple is in the initial configuration, as shown in FIG. 5A.

It should be understood that although embodiments of the surgicalbending instrument have been discussed in combination with the surgicalstaple 116, the surgical bending instruments 100, 160, 196 are not to belimited to distracting surgical staples. Rather, the surgical bendinginstruments 100, 160, 196 may be used in various capacities other thanas described herein, such as by way of non-limiting example, bending abone fusion plate so as to tailor the plate to a specific anatomy of apatient's bone being treated. Accordingly, it is envisioned that thesurgical bending instruments 100, 160, 196 may be packaged into sterilesurgery-specific kits comprising other surgical tools and components,such as by way of non-limiting example, drill guides, drill sizers,tamps, forceps, staple removal tools, drills, temporary pins, drilldepth stops, fusion bone plates, bone plate fasteners, compressionscrews, and the like. Further, the surgical bending instruments 100,160, 196 preferably comprise a rigid material suitable for bendingsurgical implants, such as surgical staples and bone fusion plates, asdescribed herein. In some embodiments, the surgical bending instruments100, 160, 196 comprise metal, plastic, or a combination of the two.

While the invention has been described in terms of particular variationsand illustrative figures, those of ordinary skill in the art willrecognize that the invention is not limited to the variations or figuresdescribed. In addition, where methods and steps described above indicatecertain events occurring in certain order, those of ordinary skill inthe art will recognize that the ordering of certain steps may bemodified and that such modifications are in accordance with thevariations of the invention. Additionally, certain of the steps may beperformed concurrently in a parallel process when possible, as well asperformed sequentially as described above. To the extent there arevariations of the invention, which are within the spirit of thedisclosure or equivalent to the inventions found in the claims, it isthe intent that this patent will cover those variations as well.Therefore, the present disclosure is to be understood as not limited bythe specific embodiments described herein, but only by scope of theappended claims.

1.-19. (canceled)
 20. A method of using a surgical bending instrumentfor implanting a surgical staple at a bone fixation or fusion site of apatient, comprising: loading the surgical staple into a distal forceapplicator of the surgical bending instrument, such that the surgicalstaple is in contact with a first grip and a second grip; advancing adriver into forceable contact with a crown of the surgical staple, thesurgical staple being clasped between the first grip, the second grip,and the driver; distracting the surgical staple, such that a first legand a second leg of the surgical staple are parallel to one another;inserting the surgical staple through an incision and sliding the firstand second legs into parallel holes drilled across a bone fusion orfixation site of the patient; retracting the driver from the crown so asto allow the surgical staple to compress the bone fusion or fixationsite; disengaging the first and second grips from the crown; pushing thesurgical staple into the parallel holes until the crown is in contactwith the patient's bone; and closing the incision by way of suturing.21. The method of claim 0, wherein advancing further comprises rotatinga proximal handle clockwise so as to move the driver distally intocontact with the crown, the driver being connected to the proximalhandle by way of a threaded shaft extending longitudinally through thesurgical bending instrument.
 22. The method of claim 0, whereindistracting the surgical staple further comprises twisting the proximalhandle clockwise to move the driver distally into the crown until thefirst and second legs are parallel with one another.
 23. The method ofclaim 0, wherein retracting further comprises rotating the proximalhandle counterclockwise so as to move the driver proximally away fromthe crown, thereby allowing the first and second legs to bend toward oneanother.